Kornimate/medical-research-clean huggingface dataset:
study on the cardioprotection and humoral mechanism of limb ischemia preconditioning

Conditions: Ischemic Preconditioning

Summary: numerous studies have shown that limb ischemic preconditioning can protect vital organs (including the heart) from ischemia-reperfusion injury,which has a broad application prospect.but its mechanism is still unclear. evidence showed that humoral mechanisms may play an important role. this study was carried out on the limb ischemic preconditioning in healthy volunteers, collected their serum at different time points before and after treatment,classified and identified the serum proteins during different periods of limb ischemic preconditioning,by using methods including high abundant protein removal,two-dimensional electrophoresis chromatography and mass spectrometry,then analysed activation and synthesis of the proteins in order to search for the proteins or peptides whose synthesis was activated by ischemic preconditioning. this study will be the first systemic explore of the changes in serum proteins of limb ischemic preconditioning in human body,and lay theoretical basis for the clinical application of limb ischemic preconditioning and for further explore of its humoral mechanism,thus provide clues for searching for protein or peptide having protective effects for organs.

we aim to assess whether limb ischemic preconditioning protects remote tissue or organs through a humoral mechanism.

Eligibility criteria:
inclusion criteria: * healthy volunteers aging 20-30 years old * no cardiac，hepatic or renal，peripheral vascular diseases * be willing to enter our study and sign an written informed consent exclusion criteria: * younger than 20 years old or older than 30 years old * having cardiac，hepatic or renal，peripheral vascular diseases * refuse to enter our study or sign an written informed consent

Keywords: ischemic preconditioning,serum proteins,human
impact of music in colonoscopy

Conditions: Colonoscopy; Music; Pain

Summary: the study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. the music is chosen by the patients themselves. the null hypothesis: the comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant. alternative hypothesis: the comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.

in the field of endoscopy, stress and pain play a relevant role before and during the examination. a variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. especially the use of relaxation music. however, the previous studies refer to a subjective assessment of the participants after the examination. here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. pain reactions express themselves explicitly in autonomous function. in contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction. the activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface: * in the face area (corrugator, zygomaticus) * on the hand (skin conductance, temperature) * on the torso (electrocardiogram) the satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.

Eligibility criteria:
inclusion criteria: * indication for colonoscopy * conscious sedation with propofol * asa state 1 or 2 exclusion criteria: * lack of written informed consent * pregnancy * general anaesthetics * asa state \>2 * deafness, hearing impairment

Keywords: colonoscopy music relaxation satisfaction
anaconda long term sedation study

Conditions: Intubated Requiring Sedation for Greater Than 48 Hours

Summary: heavy sedation or sleep is a common problem within the intensive care unit (icu) using our standard intravenous medications. this commonly leads to confusion, low blood pressure, slow wake up and removal of the artificial breathing tube (extubation), which prolongs icu stay. using inhaled volatile anesthetic agents are likely to improve these patient outcomes. this unique project is the first north american study looking at using volatiles for patients who need longer-term icu sedation. this project has excellent potential at lowering these complications and improving quality of care, which will lower patient icu stay and healthcare costs.


Eligibility criteria:
inclusion criteria: * adult icu patients expected to be ventilated \> 48 hours exclusion criteria: * age \< 18 years * history of malignant hyperthermia * propofol infusion syndrome * evidence of raised intracranial pressure * 6-month mortality risk from pre-existing condition \> 50% * lack of commitment to maximal treatment * pregnant * nebulizedflolan * tidal volume \<350ml * patients on one lung ventilation

Keywords: mechanical ventilation volatile sedation intravenous sedation delirium
inspiratory muscle training for breathless patients with chronic obstructive pulmonary disease and heart failure

Conditions: Pulmonary Disease, Chronic Obstructive; Heart Failure, Systolic

Summary: the purpose of this study is to determine whether inspiratory muscle training is effective to improve breathless and exercise intolerance in symptomatic patients with chronic obstructive pulmonary disease (copd) plus chronic heart failure (hf).

chronic obstructive pulmonary disease (copd) and heart failure with reduced left ventricular ejection fraction (hf) are leading causes of disability and death worldwide. unfortunately, copd and hf coexist in up to a third of elderly patients making the so-called copd-hf overlap (cho) a major challenge to health care systems. in addition, population ageing anticipates that cho prevalence will further increase in the next decades. intolerance to exertion due to disabling breathlessness is the hallmark of copd and hf and these abnormalities are notoriously potentiated by diseases coexistence. the inspiratory muscles are centrally related to the pathophysiology of exertional dyspnea in copd and hf. in both populations a higher central motor command output is required to maintain adequate force generation in the face of weaker inspiratory muscles. this information is interpreted as "shortness of breath". there is well established evidence gained from recent meta-analyses indicating that inspiratory muscle training (imt), as a standalone therapy, significantly improves inspiratory muscle function (strength and endurance), dyspnea during daily activities, and functional exercise capacity in copd and hf. previous findings indicate that reduced pressure-generating capacity reflecting inspiratory muscle weakness is frequently observed in patients with copd-hf and related to a clinically-relevant outcome: exertional dyspnea. these findings set the scene for a randomized controlled trial to investigate the potential role of imt in dyspnea palliation in cho patients. objectives to determine the effects of imt on: 1. dyspnea on daily life 2. inspiratory muscle strength and endurance 3. dyspnea on exertion and time to exercise intolerance

Eligibility criteria:
inclusion criteria: * previous diagnoses of copd and hf under optimized clinical treatment as judged by the accompanying physician * reduced left ventricular ejection fraction (\<50%) * non-reversible airway obstruction (post-bronchodilator fev1/fvc \< 0.7 and fev1 \< 80 %) * respiratory muscle weakness (pi,max \< 70cmh2o) * persistent dyspnea on daily life (baseline dyspnea index focal score \<or= 8). exclusion criteria: * inability to perform exercise tests * diagnosed psychiatric or cognitive disorders * progressive neurological or neuromuscular disorders having a major impact on exercise capacity
a new agent gm-ct-01 in combination with 5-fu, avastin and leucovorin in subjects with colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-fu) plus a davanat (carbohydrate polymer) along with avastin and leucovorin (lv) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.

this is a phase ii, multi-center study of davanat which has been shown to increase the anti-tumor activity of 5-fu in mice. 5-fu is a chemotherapy drug commonly used to treat tumors. a phase i study of 40 patients showed that davanat in different doses plus 5-fu was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.

Eligibility criteria:
inclusion criteria: * 18 years or older. * histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage iii and iv), not amenable to curative surgery or radiotherapy. * intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan, * presence of at least 1 measurable lesion, * have a life expectancy of at least 4 months. * women of childbearing potential, have a negative serum pregnancy test at screening and day 1 treatment and agree to practice abstinence or use an effective method of contraception. exclusion criteria: * central nervous system metastasis. * bony metastasis as the sole metastasis. * received any prior first-line chemotherapy for colorectal cancer. * previously exposed to davanat® or avastin®. * known or clinically suspected infection with hiv. * participated within 30 days or will participate concurrently in another investigational drug or vaccine study. * history of drug or alcohol dependence in the past 3 years. * other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Keywords: colorectal cancer, davanat, colon cancer, 5-fu
pmr versus mld on rls and sleep quality in hemodialysis patients

Conditions: Hemodialysis Complication

Summary: progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients

restless legs syndrome (rls) is a sensory motor disturbance with features of both neurologic and sleeps disorders. the patients complain of strong, irresistible urge to move the legs, often accompanied by uncomfortable sensations deeply in the legs. poor sleep quality affects many hemodialysis patients and can potentially predict their morbidity, mortality, quality of life and pattern of medication use. progressive muscle relaxation (pmr) is one way to improve physical work capacity and reduce functional limitations. manual lymphatic drainage (mld) is a traditional therapy in which the hands work on the tissues of the body, including tuina, acupressure, and the likes. it is beneficial to the well-being of patients both physically and mentally

Eligibility criteria:
inclusion criteria: * male and female adults ranging from 35- 65 years old. * able to communicate verbally and agree to participate in the study. * on maintenance arteriovenous fistula (avf) hemodialysis 3 times weekly. * none of the research participants had a lower extremity dialysis graft, and they were all taking medication to maintain their health. * prior to the study procedure, all patients underwent a nephrologist assessment * all patients had good compliance with their dialysis treatment (not missing more than 2 dialysis sessions in the prior 3 months exclusion criteria: * peripheral neuropathy or vascular diseases of the lower limbs. * skin diseases including acute psoriasis or eczema. * recent fractures or lower limbs surgeries. * feet injuries including severe muscle weakness, bruises, ulcers, open wounds or recent burns
the impact of post-operative voiding trial on length of stay following laparoscopic hysterectomy: a prospective, randomized control trial

Conditions: Minimally Invasive Surgical Procedure; Hysterectomy; Urinary Retention

Summary: the aim of this study is to investigate the impact of an active voiding trial compared to a passive voiding trial on time to discharge following a planned same day discharge laparoscopic hysterectomy. the investigators hypothesize that performing an active voiding trial will assess urinary function and lead to a reduction in length of stay.

following laparoscopic surgery with hysterectomy, there is no standard method for assuring urinary function prior to discharge. total laparoscopic hysterectomy (tlh) has been demonstrated to be safe with a reduction in post-operative morbidity and length of hospital stay with no difference in cancer related outcomes in endometrial cancer. furthermore, the investigators have demonstrated that following the adoption of same day discharge, there was no difference in composite complication rates or readmissions. awaiting a passive void trial may impact time to discharge as well as same day discharge; however, this has not been clearly studied in this patient population. the aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery unit compared to a passive voiding trial with removal of the foley catheter in the operating room at the end of the procedure. secondary outcomes include time to void, catheter replacement, discomfort with the voiding trial, and overnight admission.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease * planned same day discharge surgery exclusion criteria: * history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding * bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria) * surgical cases converted to laparotomy or open surgery * surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission
internet-based intervention in cardioverter-defibrillator patients to enhance quality of life

Conditions: Heart Diseases; Implantable Cardioverter-Defibrillators

Summary: the implantable cardioverter defibrillator (icd) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. a web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in icd patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet. the purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.


Eligibility criteria:
inclusion criteria: * patients implanted with a cardioverter-defibrillator (icd) * between 18-75 years of age * speaking and understanding dutch * with access to the internet and ability to use the internet * providing written informed consent exclusion criteria: * a life expectancy less than 1 year * a history of psychiatric illness other than affective/anxiety disorders * on the waiting list for heart transplantation * with insufficient knowledge of the dutch language

Keywords: anxiety icd concerns quality of life
outpatient evaluation of patients with known or suspected heart disease

Conditions: Heart Disease

Summary: this study is designed to screen patients with heart diseases who may qualify to participate in other research studies being conducted by the cardiology branch of the national heart, lung, and blood institute (nhlbi). patients participating in this research study will be seen on an outpatient basis and undergo a general medical evaluation, including blood tests, urine, examination, chest x-ray and electrocardiogram (ekg). in addition, patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform an exercise stress test. patients participating in this study will not receive any investigational treatments.

this protocol permits outpatient screening of patients with cardiovascular diseases who may be candidates for participation in current cardiology branch research protocols. no investigational treatments will be administered on this protocol.

Eligibility criteria:
must not be enrolled in an active cardiology branch research protocol. the patient must be of scientific interest to the cardiology branch, as determined by the investigator. patient is being screened for participation in an active protocol.

Keywords: heart disease screening follow-up
the use of heliox in obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the goals of the project is to evaluate the effects of heliox therapy on obstructive sleep apnea syndrome (osas).

obstructive sleep apnea syndrome (osas) is a common condition affecting up to 2-4 % of the general population. the pathophysiologic consequences of osa include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (htn), stroke and possibly coronary artery events. in addition, patients with severe and untreated obstructive sleep apnea (osa) have increased mortality compared to patients with treated severe osa.the main stay of treatment of osas is the application of continuous positive airway pressure (cpap) during sleep. the main problem with cpap therapy is compliance. heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. in this study, the investigators will evaluate the effectiveness of heliox in the treatment of osas. adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for cpap titration will be evaluated.

Eligibility criteria:
inclusion criteria: * adults 18 or older with obstructive sleep apnea syndrome (osas) presenting for cpap titration. exclusion criteria: * professional singers. * television or radio hosts. * disk jockeys. * subjects requiring oxygen therapy. * subjects younger than 18 year old. * pregnant women. * patients with chronic obstructive pulmonary disease (copd) with forced expiratory volume 1 (fev1) less than 50%. * history of anatomic upper airway obstruction. * uncontrolled asthma.

Keywords: heliox obstructive sleep apnea
adi-peg in patients with metastatic melanoma

Conditions: Melanoma; Neoplasm Metastasis

Summary: this is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (adi-peg) in patients with nonresectable metastatic melanoma.

the use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. recently it has been shown that human melanomas are auxotrophic for arginine. as arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (adi) coupled to polyethylene glycol (peg) to enhance its circulating half-life. in this study, patients each receive 3 intramuscular treatments of adi-ss peg over a 4-week period. there are 4 cohorts of patients each receiving a different dose level. pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic melanoma * nonresectable disease * measurable or evaluable disease * progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy * recovered from prior surgery * karnofsky performance status 70 or higher * expected survival of at least 12 weeks * bilirubin less than 2.0 mg/dl * albumin greater than 3.0 g/dl * sgot less than 5 times upper limit of normal (uln) * alkaline phosphatase less than 5 times uln * ammonia less than 55 microg/dl * glucose greater than 60 mg/dl * amylase less than 1.5 times uln * absolute neutrophil count greater than 1,500/mm3 * platelet count greater than 100,000/mm3 * patients must use 2 forms of effective contraception exclusion criteria: * prior therapy within the past 4 weeks * ascites or pleural effusion * significant cardiac disease (i.e., new york heart association class iii or iv heart disease) * pregnant or nursing * concurrent enrollment in another ind study * serious infection requiring antibiotics

Keywords: dose-response relationship, drug polyethylene glycol arginine deiminase
lateral sinus floor elevation in implant therapy.

Conditions: Edentulous; Alveolar Process, Atrophy

Summary: the l-prf block is a combination of bone substitute with l-prf. the use of a l-prf block in bone augmentation therapies could enhance and improve bone regeneration. the primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.

this is a randomized controlled clinical trial. a total of 24 patients, needing sinus lift with lateral window technique (l), will be enrolled. all patients have to fulfil all of the inclusion and none of the exclusion criteria. the trial will comprise 8 visits. written informed consent will be obtained prior to any examination carried out for study purposes. randomization will be performed using sealed, sequentially numbered, opaque envelopes containing treatment allocation. under local anaesthesia, the required l will be performed. once the blood extraction is done the surgery can start following the normal procedure for the lateral approach of sinus floor elevation. once the preparation of the sinus floor elevation is done the randomization envelopes will be open and the selected treatment will be applied. for the test group the sub-sinus cavity will be filled with l-prf block and the window will be closed with l-prf membranes. for the control group the sub-sinus cavity will be filled with only dbbm and the window will be closed with a collagen membrane. afterwards suturing will be conducted and a cbct will be taken for control and observation. after 6 months the subjects return for a check-up of the healing process. a cbct will be taken to assess the bone regeneration. implant surgery will be discussed. with a crestal incision the implant site will be exposed. a trephine bur of 3 mm in diameter will be use to obtain a biopsy of the test or control site. this will result in a biopsy sample of the healed site. at the exact same location of the biopsy the drilling will be performed according to implant protocol and the implant will be placed and isq values will be recorded. follow-up will be till 1 year.

Eligibility criteria:
inclusion criteria: * provision of informed consent * need for l and oral implant placement. * rbh \<4mm * rbh \>4mm, but no t possible (due to anatomy) exclusion criteria: * unlikely to be able to comply with the study procedures, as judged by the investigator * untreated periodontal disease * unfavorable plaque control * known or suspected current malignancy * history of chemotherapy within 5y prior to study * history of radiation on the head and neck region * history of other metabolic bone diseases * need for systemic corticosteroids * current or previous use of intravenous/oral bisphosphonates * present alcohol and/or drug abuse * involvement in the planning and conduct of the study * psychiatric disorders which do not allow a normal treatment outcome